The salford lung study is an openlabel, phase 3b, controlled, multicentre, randomized clinical trial mainly aimed at comparing the safety profile and effectiveness of ffvi treatment and the current copd therapy. Use of patients linked electronic health records to collect clinical endpoints offers minimal disruption to patients and investigators, and also ensures patient safety. The salford lung study is the worlds first pragmatic randomised controlled trial of a prelicensed medication in asthma. The salford lung study is a phase iii multicentre, open label randomised controlled trial. Sep 06, 2016 glaxosmithkline gsk has announced full results from the salford lung study sls, a pioneering study of copd treatment aimed at creating a clinical trial much closer to everyday clinical practice. The study utilises the salford electronic medical record, which allows near to realtime collection and monitoring of safety data. Salford lung study for the conduct of an observational study comparing the generalisability of sls patients to those in cprd. Start with the word in, followed by the author or editor of the work, its date, the title, the.
And i was one of the leads on the salford lung study. Realworld data on the benefitrisk profile of medicines is needed, particularly in patients who are ineligible for randomised controlled trials conducted for registration purposes. Use of ehr data to support a pragmatic trial hypothetical example presented in white paper revised dosing schedule may be safer and equally efficacious compared to that which is approved in the label salford lung study serves as a backdrop copd. Today im going to be talking about the salford lung study, in copd. Anonymised individual participant data from this study plus the annotated case report form, protocol, reporting and analysis plan, dataset specifications, raw dataset, analysisready dataset and clinical study report are. A randomised effectiveness study comparing fluticasone. Sep 04, 2015 the salford lung study sls is the worlds first pragmatic rct prct of an investigational medication. The salford lung study was a clinical trial which began recruitment in 2012, with the basis that enrolment would be open to a much broader population with a diagnosis of chronic obstructive pulmonary disease copd or asthma in the region, regardless of whether or not they had other conditions such as cancer or high blood pressure. Dbrcts, using the salford lung study sls programme as an illustrative example. The extended salford lung study ex sls data access project the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The salford lung study in copd sls copd was a clinical trial conducted in a uk primary care population that was designed to be representative of patients with copd in routine clinical practice.
Biocentury salford study reveals realworld asthma outcomes. This study was conducted to evaluate the effectiveness and utility of breo fluticasone furoate and vilanterol in reducing copd exacerbations in patients compared to current. Sep 08, 2016 glaxosmithkline and innoviva have finally provided greater detail on the salford lung study at the european respiratory congress. Initiated in 2012, the salford lung study was a 12month, openlabel, phase iii pragmatic randomized controlled trial prct sponsored by glaxosmithkline and conducted in the salford borough of the greater manchester area in the united kingdom 3. Salford lung study study design1,2 2,802 copd patients usual care. Study investigating the generalisability of a copd trial. American association for cancer research american society of. The objective of this study was to compare the effectiveness and safety profile of initiating treatment with ffvi with usual asthma maintenance therapy over. Relvar ellipta significantly improved asthma control in. This paper describes the methodology and source data verification which enables the conduct of prelicensing clinical trials of copd and asthma in the community using the electronic medical.
Salford lung study in chronic obstructive pulmonary disease. Second annual dukemargolis conference on realworld data. Safety was also assessed and the safety profile of ffvi in the salford lung study was consistent with the product label for ffvi. The sls, sponsored by gsk, examined the safety and effectiveness of a new treatment for chronic obstructive pulmonary disease copd and asthma. The salford lung study is an openlabel phase iii prct of a oncedaily longacting. The study generated effectiveness and safety data for relvar fluticasone furoatevilanterol ffvi, 9222 mcg in a population of patients with copd intended to represent that seen in everyday clinical practice. Evidence notes issue seven june 2016 issue seven june 2016. Promising copd data revealed for relvar ellipta in salford.
Dec 10, 2015 the study utilises the salford electronic medical record, which allows near to realtime collection and monitoring of safety data. Salford shows realworld studies arent for the fainthearted, and can be expected to frequently deliver a dose of harsh reality. Healthcare professionals from eight organisations across greater manchester have collaborated to deliver the initial results of the salford lung study sls. Effectiveness of fluticasone furoate vilanterol for copd. The highly anticipated results from the salford lung study were announced by gsk on 5th may 2017. A second salford lung study is currently being conducted in asthma patients, with results expected in 2017. Realtime patient safety monitoring in clinical trials. The salford lung study is a phase iii multicentre, open label randomised controlled trial rct.
Salford lung study asthma results published northwest ehealth. The design of the study was such that the involvement of community pharmacy was a crucial element. Reducing patient burden remote endpoint monitoring. Robust effectiveness evidence would be of particular value in assessing oncedaily inhaled therapies for asthma and copd, where improved outcomes may result from better adherence. Relvar ellipta significantly improved asthma control in salford lung study patients compared with their usual care. Many companies will be reluctant to spend this amount of money. The salford lung study the salford lung studies were the worlds first phase iii pragmatic randomised clinical trials of a novel drug therapy. The study involved over 2,800 consenting patients, supported by 80 gp practices and pharmacies in salford and the surrounding greater manchester area. Realworld evidence rwe is evidence derived from rwd through the application of research methods. Pioneering gsk study provides important new data on the effectiveness of relvar ellipta ffvi when used in everyday clinical practice. The salford lung study is the worlds first pragmatic, realworld study initiated on what was, at the time, a prelicence medicine.
Chair of the pharmacy steering group for the salford lung study and european pharmacy adviser for gsk. Jun 01, 2016 lead investigator jorgen vestbo, professor of respiratory medicine at the centre for respiratory medicine and allergy, university hospital south manchester nhs foundation trust and the university of manchester, said the salford lung study is an important trial to help us understand more about the medicines prescribed on a daily basis. We now report the results of the salford lung study on asthma, which compared the effectiveness of the. Salford lung study asthma results published northwest. A pragmatic, randomised phase iii realworld effectiveness trial in asthma article pdf available in bmc pulmonary medicine 151. Realworld evidence and the quest for european market access. The salford lung study is important as one of the first clinical effectiveness studies of its kind, providing interesting insights into the management of asthma in clinical care. This paper describes the methodology and source data. The usual way of investigating new medicine is to use a double blind, randomised controlled trial rct the gold. Salford lung study ambition study is as near to real world as possible using a prelicense medicine embrace heterogeneity of patient population normalise the patient experience as much as possible pragmatic usual care in each arm relevant endpoints collected maintain scientific rigour interventional. Using a broad and inclusive population of patients, the study evaluated the effectiveness and safety of a new treatment for chronic. Using an electronic medical record emr to conduct clinical. The salford lung study is a recently published clinical trial seeking to demonstrate superiority of a new copd therapy to standard of care.
Second annual dukemargolis conference on realworld data and. Positive results from pioneering salford lung study in. Apr 20, 2017 the salford lung study has been designed to explore how effective a treatment for chronic obstructive pulmonary disease, or copd, and asthma is, when it is used in everyday clinical practice. This difference means that subtle benefits from an improved inhaler or a oncedaily regimen could occur in an effectiveness study done in a routine care setting. Salford lung study in chronic obstructive pulmonary. The innovative realworld setting was a risk, but ultimately gsk. Salford lung study ambition study is as near to usual care real world as possible using a prelicense medicine embrace heterogeneity of patient population normalise the patient experience as much as possible pragmatic usual care in each arm relevant endpoints collected maintain scientific rigour. Copd and asthma prevalence is associated with socioeconomic status or deprivation, yet deprivation is rarely considered in typical largescale efficacy randomised controlled trials that recruit highly selected patient populations. Research article open access using an electronic medical record emr to conduct clinical trials. The salford lung study sls is the worlds first pragmatic rct prct of an investigational medication. May 06, 2017 the study is gsks second realworld outcomes trial evaluating relvar ellipta, which it markets to treat asthma and chronic obstructive read the full 472 word article this article and the information contained in biocenturys publications and services are solely for your own personal, nontransferable licensed use and cannot be shared with. The salford lung study, conducted through a multistakeholder partnership in salford, uk, is the worlds first pragmatic trial of an investigational medication.
Putting patients in control of data from electronic health. Sls copd was a 52week, prospective, comparative, openlabel, randomised controlled trial rct conducted in the city of salford in the uk. Effectiveness of fluticasone furoate plus vilanterol on. The salford lung study the salford lung study is an openlabel phase iii prctof a oncedaily longacting. Realworld evidence to guide the approval and use of new. Describe what made the salford lung study so pioneering in its research methodology. What im going to be talking about, is a little bit about the background of this study, why we did it, a little about how we did it, and also tell you a bit about the results, and some of the outcomes from this study. Explain the bespoke it infrastructure used to support the safety monitoring and reporting during the salford lung study.
Incorporating evidence from clinical experience into. Dec 10, 2015 novel therapies need to be evaluated in normal clinical practice to allow a true representation of the treatment effectiveness in realworld settings. Real world data rwd are data relating to patient health status andor the delivery of health care routinely collected from a variety of sources common types. Asthma control and differences in management practices across seven european. The salford lung study on copd5 showed that, compared with continuation of usual care, initiation of the oncedaily combination of fluticasone furoate and vilanterol reduced moderate and severe exacerbations. Analyze patient safety monitoring challenges and how to use real world studies to assess the effectiveness of new drug therapies. While not all 35 children in the group have asthma, in the trail project the 6 children. The salford lung study is a pragmatic randomised controlled trial in adult asthma, evaluating the clinical effectiveness and safety of oncedaily fluticasone furoate 100. Challenges and complexities with the reporting of electronic medical record data in a pioneering phuse 2018, frankfurt 6 and novel approach to clinical trials manchester london salford randomised openlabel, parallel group design 12. The salford lung study sls of patients with asthma and chronic obstructive pulmonary disease copd is a practical, communitybased, randomized, openlabel pragmatic study on the efficacy and safety of the oncedaily dry powder inhaler that combines the inhaled corticosteroid fluticasone furoate ff with the longacting beta2 agonist vilanterol. Set in salford and southern manchester districts, uk the sls asthma study rw01. Salford lung study results show copd patients treated with.
Use of patients linked electronic health records to collect clinical endpoints offers minimal disruption to patients and. Salford lung study shows reduction in copd exacerbations with. The salford lung study is a phase iiib multicentre, open label randomised controlled trial rct. In the study for the intenttotreat itt population, the incidence of serious adverse events sae was the same in both arms ffvi % and usual care %. The study gsk sponsored study from salford, uk compared the use of once a day inhaled corticosteroid against normal standard of care for copd and asthma patients. Headline results from the 2,802patient salford lung study sls in copd demonstrated that the inhaled therapy achieved a superior reduction in exacerbations versus usual care which included longacting muscarinic antagonists lama, longacting beta2agonists laba, and inhaled corticosteroids ics in an everyday clinical practice setting. Evidence notes issue seven june 2016 3 according to the authors, the salford lung study in asthma and copd is worlds first preapproval phase iii randomised pct21 and, although ongoing, is a useful case study to explore. Study is as near to real world as possible using a pre license medicine.
Following this, if you have any issues or complaints, you may contact the research supervisor xxx by email. Impact of socioeconomic status on participation and. In a casecontrol study, capture exhibited a sensitivity of 95. End of study visit randomisation visit randomisatan roelite cewice routine resnmcry 3 phone usual care physician freechoice of copo maintenance treatment eatment a. Jun 02, 2016 study results are currently under evaluation. This study is an example of collaboration and community pharmacys contribution in a large multi disciplinary study.
Sir helped to quantify the burden of asthma and chronic obstructive pulmonary disease copd, identified exacerbations, and evaluated differences in disease outcomes and healthcare resource use in salford. By contrast, in the salford lung studies, apart from the baseline and 12month visits, there were no planned facetoface visits with the study team. Listing a study does not mean it has been evaluated by the u. Salford lung study in asthma relvar ellipta fluticasone. This article was published on september 4, 2016, at. A second salford lung study is also being conducted in patients with asthma. Compare, in a realworld setting, the safety and efficacy of relvar ellipta, with existing maintenance therapy for copd and asthma in a general practice setting in the uk provide relevant and. Similarly, improved lung health is hard to measure in the short term and thus, as the project is not yet complete, hard to measure. Gsks relvar ellipta hits the mark in copd trial pharmatimes.
The objective of the study was to compare the effectiveness and safety profile of ffvi 10025mcg with existing copd usual care. Pdf using an electronic medical record emr to conduct. Nov 22, 2016 glaxosmithkline plcs groundbreaking salford lung study was only possible because salford, in greater manchester, uk, was a truly paperless center that had had for some time an integrated ehealth record system shared between primary and secondary health care, says david leather, md, gsks global medical affairs leader in the respiratory. This study develops novel methods to evaluate the presence of a hawthorne effect operating for a trial, such as the salford lung study in copd, which was conducted in the setting of everyday clinical practice. I am coinvestigator of this observational study i have participated in advisory meetings with gsk, novonordisk, sanofi and novartis on pragmatic trials some of the slides were provided by gsk but contents of.
Salford lung study reports successful asthma trial. In this post hoc analysis of the salford lung studies in copd and asthma two 12month, openlabel, effectiveness. Positive results from pioneering salford lung study in asthma. The results of the successful asthma arm of the salford lung study sls have been announced. As part of assessing the feasibility of future pragmatic trial utilizing nwehldb, a retrospective cohort study to identify anonymised patients with a coded diagnosis of either asthma or copd in salford using compatible read codes during 2008 with follow up through 2009 was conducted, using data from all registered practices in salford. Participant information sheet university of salford. Sls will evaluate the effectiveness and safety of the ffvi combination compared with existing maintenance therapy in a large, realworld population of patients with copd in conditions of normal care. The salford lung study sls of patients with asthma and chronic obstructive pulmonary disease copd is a practical, communitybased, randomized, openlabel pragmatic study on the efficacy and.
592 51 697 1129 462 625 704 189 1545 6 730 1446 544 455 843 343 27 530 1125 250 284 1547 1478 904 142 1483 182 1289 217 1086 990 1469 833 207 1045 64 441